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Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes (DIABEER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03746093
Recruitment Status : Unknown
Verified October 2018 by Universidade do Porto.
Recruitment status was:  Recruiting
First Posted : November 19, 2018
Last Update Posted : January 29, 2019
Sponsor:
Collaborators:
Center for Health Technology and Services Research
NOVA Medical School
Information provided by (Responsible Party):
Universidade do Porto

Study Description
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Brief Summary:
The aim of the study is to investigate the effects of non-alcoholic beer in patients with type 2 diabetes. Subjects will be divided into two groups: the control group, where participants will be consuming a bottle of water (330ml) every day for 12 weeks, and the intervention group, where participants will be consuming a bottle of non-alcoholic beer (330ml) for the same period.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Dietary Supplement: Water Dietary Supplement: Non-alcoholic beer Not Applicable

Detailed Description:

This is a parallel, controlled randomized trial. The study will compare the effect of non-alcoholic beer consumption with water, in patients with type 2 diabetes.

All patients from both groups will receive a personalized nutritional intervention and will be followed throughout the study by a certified nutritionist.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Non-alcoholic Beer in Patients With Type 2 Diabetes: A Randomized Controlled Trial
Actual Study Start Date : November 7, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control Group
Participants will consume a bottle of water (330 ml) every day for 12 weeks.
 Dietary Supplement: Water
Participants will consume a bottle of water (330 ml) every day for 12 weeks.
Experimental: Non-alcoholic beer
Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.
 Dietary Supplement: Non-alcoholic beer
Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in fasting capillary blood glucose from baseline to visit 2 and 3 [ Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) ]
  2. Changes in fasting insulin levels from baseline to visit 2 and 3 [ Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) ]
  3. Changes in HOMA-IR from baseline to visit 2 and 3 [ Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) ]
  4. Changes in HOMA-B from baseline to visit 2 and 3 [ Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) ]
  5. Changes in HbA1c levels from baseline to visit 2 and 3 [ Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) ]

Secondary Outcome Measures :
  1. Changes in intestinal microbiota from baseline to visit 2 and 3 [ Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) ]
    Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage.

  2. Changes in body mass index from baseline to visit 2 and 3 [ Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) ]
    Weight and height will be combined to report BMI in kg/m^2

  3. Changes in total body fat mass from baseline to visit 2 and 3 [ Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) ]
  4. Changes in fasting serum total cholesterol from baseline to visit 2 and 3 [ Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) ]
  5. Changes in fasting serum high-density lipoprotein (HDL) cholesterol from baseline to visit 2 and 3 [ Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) ]
  6. Changes in fasting serum low-density lipoprotein (LDL) cholesterol from baseline to visit 2 and 3 [ Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) ]
  7. Changes in fasting serum triglycerides from baseline to visit 2 and 3 [ Time Frame: at visit 1 (after 1-week run-in period), visit 2 (after 6-week intake period), visit 3 (after 12-week intake period) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women diagnosed with type 2 diabetes mellitus, according to the American Diabetes Association criteria;
  • Ages 40-80 years;
  • Non-smoker;
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Changes in oral glycaemic-control medications in the last 3 months;
  • Subjects with HbA1c levels under 6.4% or above 10%;
  • Subjects under insulinotherapy;
  • Subjects with triglycerides levels above 4.52 nmol/L(400 mg/dL);
  • Intake of antibiotics in the last 12 weeks;
  • Subjects not willing to avoid drinking beer during the study;
  • Subjects with a diagnosis of any digestive disease including functional bowel disorders such as IBS;
  • Pregnant women or women planning to become pregnant during the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746093


Contacts
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Contact: Conceição Calhau +351218803000 ccalhau@nms.unl.pt

Locations
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Portugal
NOVA Medical School, NOVA University of Lisbon Recruiting
Lisboa, Portugal, 1169-056
Contact: Conceição Calhau    00351918482491    diabeer@nms.unl.pt   
Sponsors and Collaborators
Universidade do Porto
Center for Health Technology and Services Research
NOVA Medical School
More Information
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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT03746093    
Other Study ID Numbers: DIABEER
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases